In plain English
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Official title
A Double-blind, Placebo-controlled Study to Determine the Safety and Feasibility of Two Doses of Intravenous (2R, 6R)-Hydroxynorketamine (RR-HNK) in Adults With Obsessive-Compulsive Disorder
About this study
This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.
Eligibility criteria
Inclusion Criteria:
* Ages 18-65
* Meet the criteria for OCD diagnosis
* Failed at least 1 prior trial of standard first-line OCD treatment (e.g. SRI/CBT) or or had refused these treatments for individual reasons
* Agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures.
* Able to provide informed consent
Exclusion Criteria:
* Allergy or hypersensitivity to ketamine
* Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
* Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
* Lifetime history of deep brain stimulation
Study design
Enrollment target: 45 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-01-23
Estimated completion: 2029-11-30
Last updated: 2026-03-05
Interventions
Drug: RR-HNK/HydroxynorketamineDrug: Placebo
Primary outcomes
- • Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) (Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week)
Sponsor
Carolyn Rodriguez · other
With: National Institutes of Health (NIH)
Contacts & investigators
ContactIzzy Vo, BS · contact · ocdresearch@stanford.edu · 650-723-4095
InvestigatorCarolyn Rodriguez, MD, PhD · principal_investigator, Stanford University
All locations (1)
Stanford University School of MedicineRecruiting
Palo Alto, California, United States